CancerPARTNERSNCT06481774
Promoting Access, Resources and Treatment Through Novel and Equitable Solutions for Cancer Care
A study testing CONNECT platform in people with Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this research is to evaluate a novel, integrated approach to providing navigation services to improve cancer outcomes and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- CONNECT platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 375 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jul 2024to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- There are two levels of criteria for inclusion.
- First, investigators will identify individuals who have either had a cancer screening with a suspicious finding (ie. requires diagnostic follow-up) or those individuals who are referred to the UH Seidman Diagnostic Clinic (led by Co-I Hoehn).
- Within that group, investigators will recruit those who identify as African American, Hispanic, or living in a prioritized geography as defined by zip code ADI>=75%ile for state
Who cannot join
- Any participant who is not willing or able to complete an informed consent form will not be eligible for this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Erika Trapl, PhD, 216-368-0098, erika.trapl@case.edu
About this study
Official title: PARTNERS: Promoting Access, Resources and Treatment Through Novel and Equitable Solutions for Cancer Care
The purpose of this research is to evaluate a novel, integrated approach to providing navigation services to improve cancer outcomes and quality of life.
Read the detailed description
In a seminal paper published in 1995, Dr. Harold Freeman proposed that "Patient navigators act as patient advocates for patients with abnormal (Cancer) screening findings."Since that article was published, there has been an extensive literature to support the value of patient navigation services to promote timely and complete receipt of cancer care services for participants newly diagnosed with cancer, as well as along the continuum of cancer treatment, including among underserved populations. Despite this literature, it was not until January 2024 that the Centers for Medicare and Medicaid Services (CMS) formally recognized patient navigation as a reimbursable service in clinical settings. A key value that is attributed to PN services is the ability of navigational processes to improve equitable cancer caner service deliver for participants, irrespective of a person's social determinants of health (SDOHs) composition, including factors like financial stability, educational attainment, access to health care, race/ethnicity, and/or rurality of residence.
In response to the unmet and significant need to reduce disparities in cancer care delivery, in 2022, the Merck Foundation launched a national effort to select 8 grantees across the United States (US) to develop a national, sustainable model to improve equitable cancer care services which, in turn, should help reduce the long-standing, pervasive disparities observed in cancer outcomes for persons of minority race/ethnic status and/or SDOHs. As part of this Alliance, the Case CCC and CWRU PARTNERS study team will develop and examine elements of patient navigational processes that promote timely receipt of cancer care services, more effective patient-provider-systems-level communication around cancer care, while addressing the SDOH needs of participants and ensuring receipt of services after participant referrals ("closed loops"). This project proposes an intentional focus on engaging persons who represent medically disadvantaged or fragile populations (defined here as Greater Cleveland area residents who are Black/African American, Hispanic, and/or reside in a zip code with "high" area deprivation indices).
- Conditions
- Cancer
- Being tested
- CONNECT platform
- Keywords
- Patient navigators
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CONNECT platformBehavioural
CONNECT platform provides access to participant information across the 5 participant sites to facilitate a more holistic approach to addressing participant needs. It is the use of this cloud-based, HIPAA compliant platform that constitutes the uniqueness of this behavioral intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patient Navigation Services | Experimental | Following the consent process, participant will have access to a Patient Navigator, who will serve as a resource for during the time in the study to help navigate and get connected to local resources. The Patient Navigator will keep track of the kinds of support services and referrals provided. The Patient Navigator will contact the participant in 4 months to reassess current needs, quality of life, and areas where additional support is needed. Receives: Behavioral: CONNECT platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant improvement as measured by participant distress screening tool
Participant distress screening assessment tool is a list of questionnaire with a scale from 0-10, where 0 is none and 10 is extreme distress
Measured: 4 months
Quality of life as measured by PHQ-9 Patient Depression Questionnaire
Intepretation for PHQ-9 Patient Depression Questionnaire is based on the final score ranging from 1-27, 1-4 is minimal depression, 5-9 is mild, 10-14 is moderate, 15-19 is moderately severe, 20-27 is severe depression
Measured: 4 months
Secondary outcomes (2)
The number of social needs as measured by HRSN(Health related social need) questionnaire
HRSN is a list of 19 questions with multiple choice answers with a scale from 1-5 for each question, where 1 is never and 5 is frequently. A score of 11 or more when numerical values for anwers to questions 6-9 are added shows that the person might not be safe.
Measured: 4 months
Rate of patient satisfaction as measured by cancer care survey
Patient satisfaction with cancer care survey rate based on a scale from 1-5, where 1 is strongly disagree and 5 is strongly agree
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start30 Jul 2024
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erika Trapl, PhD, Principal investigator, Case Western Reserve University, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481774
- Sponsor's protocol ID
- CASE4Z24
- Acronym
- PARTNERS
- Status last verified
- Sep 2025
- First submitted
- 24 Jun 2024
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: As a recipient of Merck Foundation funding, investigators are obligated to collect "harmonized metrics" for program participants. This data is shared back (at the individual level) with the National Program Office. There is no PHI in this dataset, and there is no personal identifying information that is shared. The data is not shared beyond the NPO; all data shared by the NPO is aggregated and not identifiable. Additionally, investigator does not intend to share IPD with anyone outside of the NPO
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PARTNERS: Promoting Access, Resources and Treatment Through Novel and Equitable Solutions for Cancer Care
- ClinicalTrials.gov ID
- NCT06481774
- Acronym / sponsor ID
- PARTNERS / CASE4Z24
- Conditions
- Cancer
- Keywords
- Patient navigators
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 30 Jul 2024 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate a novel, integrated approach to providing navigation services to improve cancer outcomes and quality of life.
Detailed description
In a seminal paper published in 1995, Dr. Harold Freeman proposed that "Patient navigators act as patient advocates for patients with abnormal (Cancer) screening findings."Since that article was published, there has been an extensive literature to support the value of patient navigation services to promote timely and complete receipt of cancer care services for participants newly diagnosed with cancer, as well as along the continuum of cancer treatment, including among underserved populations. Despite this literature, it was not until January 2024 that the Centers for Medicare and Medicaid Services (CMS) formally recognized patient navigation as a reimbursable service in clinical settings. A key value that is attributed to PN services is the ability of navigational processes to improve equitable cancer caner service deliver for participants, irrespective of a person's social determinants of health (SDOHs) composition, including factors like financial stability, educational attainment, access to health care, race/ethnicity, and/or rurality of residence.
In response to the unmet and significant need to reduce disparities in cancer care delivery, in 2022, the Merck Foundation launched a national effort to select 8 grantees across the United States (US) to develop a national, sustainable model to improve equitable cancer care services which, in turn, should help reduce the long-standing, pervasive disparities observed in cancer outcomes for persons of minority race/ethnic status and/or SDOHs. As part of this Alliance, the Case CCC and CWRU PARTNERS study team will develop and examine elements of patient navigational processes that promote timely receipt of cancer care services, more effective patient-provider-systems-level communication around cancer care, while addressing the SDOH needs of participants and ensuring receipt of services after participant referrals ("closed loops"). This project proposes an intentional focus on engaging persons who represent medically disadvantaged or fragile populations (defined here as Greater Cleveland area residents who are Black/African American, Hispanic, and/or reside in a zip code with "high" area deprivation indices).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Navigation Services | Experimental | Behavioral: CONNECT platformFollowing the consent process, participant will have access to a Patient Navigator, who will serve as a resource for during the time in the study to help navigate and get connected to local resources. The Patient Navigator will keep track of the kinds of support services and referrals provided. The Patient Navigator will contact the participant in 4 months to reassess current needs, quality of life, and areas where additional support is needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- There are two levels of criteria for inclusion.
- First, investigators will identify individuals who have either had a cancer screening with a suspicious finding (ie. requires diagnostic follow-up) or those individuals who are referred to the UH Seidman Diagnostic Clinic (led by Co-I Hoehn).
- Within that group, investigators will recruit those who identify as African American, Hispanic, or living in a prioritized geography as defined by zip code ADI>=75%ile for state
Key exclusion criteria (1 listed)
- Any participant who is not willing or able to complete an informed consent form will not be eligible for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CONNECT platformCONNECT platform provides access to participant information across the 5 participant sites to facilitate a more holistic approach to addressing participant needs. It is the use of this cloud-based, HIPAA compliant platform that constitutes the uniqueness of this behavioral intervention. | Behavioural | Patient Navigation Services |
Primary outcome
Participant improvement as measured by participant distress screening tool
Time frame: 4 months
Participant distress screening assessment tool is a list of questionnaire with a scale from 0-10, where 0 is none and 10 is extreme distress
Quality of life as measured by PHQ-9 Patient Depression Questionnaire
Time frame: 4 months
Intepretation for PHQ-9 Patient Depression Questionnaire is based on the final score ranging from 1-27, 1-4 is minimal depression, 5-9 is mild, 10-14 is moderate, 15-19 is moderately severe, 20-27 is severe depression
2 secondary outcomes
The number of social needs as measured by HRSN(Health related social need) questionnaire
Time frame: 4 months
Rate of patient satisfaction as measured by cancer care survey
Time frame: 4 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
- Individual participant dataSharing planned: Yes. As a recipient of Merck Foundation funding, investigators are obligated to collect "harmonized metrics" for program participants. This data is shared back (at the individual level) with the National Program Office. There is no PHI in this dataset, and there is no personal identifying information that is shared. The data is not shared beyond the NPO; all data shared by the NPO is aggregated and not identifiable. Additionally, investigator does not intend to share IPD with anyone outside of the NPO
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erika Trapl, PhD principal investigator
Case Western Reserve University, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CONNECT platform in people with Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erika Trapl, PhD (216-368-0098, erika.trapl@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant improvement as measured by participant distress screening tool (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.